We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00368134
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : June 28, 2007
Sponsor:
Information provided by:
Novartis

Brief Summary:
This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes
Study Start Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in HbA1c after 12 weeks

Secondary Outcome Measures :
  1. Change in FPG after 12 weeks
  2. Change in Fasting Lipids after 12 weeks
  3. Change in HOMA-IR after 12 weeks
  4. Change in HOMA-B after 12 weeks
  5. Safety Profile after 12 weeks treatment


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diagnosis as Type 2 Diabetes
  • Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
  • Outpatients

Exclusion Criteria:

  • Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases
  • Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368134


Locations
Japan
Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00368134     History of Changes
Other Study ID Numbers: CLAF237A1301
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: June 2007

Keywords provided by Novartis:
Type 2 Diabetes
Vildagliptin
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Voglibose
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors